- Colgate-Palmolive (Piscataway, NJ)
- …Master Data Data Governance policies + Partner with Quality on documentation required for FDA Part 11 Computer System Validation + Manage Digital Library ... to end system testing to evaluate functionality and performance + Handle and author FDA validation documentation ( Validation Plans, IQ, IQ, PQ protocols,… more
- Boehringer Ingelheim (Athens, GA)
- …reflect Boehringer Ingelheim's high regard for our employees. The Principal Specialist, Validation manages all phases of higher level, more complex validation ... project activities at the BIAH location from concept through process validation ensuring GxP regulatory compliance continues as outlines in BIAH's Validation … more
- Catalent Pharma Solutions (Harmans, MD)
- **Senior Engineer, Computer Systems Validation ** **Position Summary:** Catalent is a global, high-growth, public company and a leading partner for the ... is hiring a Senior Engineer, CSV who is responsible for participating in validation projects related to manufacturing equipment, critical computer systems and… more
- PCI Pharma Services (Bedford, NH)
- …Collaborate with departments inside the organization to maintain and improve computer system validation processes to ensure robust, efficient, and ... electronic record and electronic signature assessments. + Generate and execute validation (IQ, OQ, and PQ) documentation for computer /computerized systems… more
- Eastman (Kingsport, TN)
- …Computerized Systems across their lifecycle, ensuring adherence to regulatory standards, Computer Systems Validation (CSV), and Data Integrity requirements. They ... systems. Responsibilities + Develop 21 CFR Part 11 compliant computer systems validation plans, IQ/OQ qualification test...biotechnology or other manufacturing life science industries regulated by FDA . + A Master's degree in Computer … more
- BioFire Diagnostics, LLC. (Hazelwood, MO)
- …as needed. + Act as a subject matter expert on part 11 requirements and computer system validation (CSV). + Review and approve validation documentation ... is required. + Competence in Medical Device Development Processes and/or Computer System Lifecycle validation compliance demonstrated by relevant industry… more
- PCI Pharma Services (Philadelphia, PA)
- …sterilization process. This includes strong working knowledge of ISO 14937, ISO 11135, FDA Process Validation Guidance, and EMA Annex 15, Qualification, ... + Strong working knowledge of ISO 14937, ISO 11135, FDA Process Validation Guidance, and EMA Annex...experience + Statistical and Advanced Mathematical Skills + Advanced Computer Skills: Ability to perform the most complex … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. **Summary** Manage Global DX Computer System Validation (CSV) projects within Daiichi Sankyo, for ... Sankyo requirements, and business expectations. Executes the Global DX Computer System Validation methodology to determine the...required - 1 or More Years Direct dealings with FDA , EMA, PMRA, other regulatory agencies. preferred - 1… more
- ThermoFisher Scientific (Greenville, NC)
- …of validation principles, including equipment, process, and computer system validation . * Detailed knowledge of cGMP, FDA , EMA, ISO, and other regulatory ... Standards, Office **Job Description** **Job Summary:** The Senior Manager of QA Validation will provide oversight and manage the validation activities across… more
- Bristol Myers Squibb (Warren, NJ)
- …their personal lives. Read more: careers.bms.com/working-with-us . **Title: Assistant Validation Engineer (CSV)** **Location: Warren, NJ** The **CSV Assistant ... compliance with policies, guidelines, and procedures. Through this work, the validation engineer supports the successful operation of facility, laboratory and… more
- Catalent Pharma Solutions (Madison, WI)
- …has oversight of the validation program, including commissioning and qualification, cleaning validation , and computer system validation as well as the ... **Engineer III - Validation ** **Summary** Catalent Biologics is a fast-growing business...The department's primary function is to ensure compliance with FDA and other regulatory agency requirements as well as… more
- Curia (Albuquerque, NM)
- …and manufacturing process protocols and final report. + Review and approve validation protocols for computer related systems (as needed), environmental ... mapping and use of Kaye Validator + Experience with FDA and EU regulations for pharmaceuticals and validation...form and deal with several abstract and concrete variables. Computer Skills: The ideal candidate will possess a strong… more
- Novo Nordisk (Clayton, NC)
- …us make what matters. The Position Primary responsibility is to provide/lead validation services required for the successful delivery of IT & Automation projects. ... Senior Project Manager, Site Capacity & Upfit. Essential Functions + Provide validation & technical support through the preparation, execution, data analysis, &… more
- Integra LifeSciences (Plainsboro, NJ)
- …or more of the following areas of validation : * Equipment Qualification * Process Validation * Cleaning validation * Computer System Validation * ... a production setting. **Responsibilities** + Generation and execution of qualification/ validation protocols including the generation, routing and approval of summary… more
- Abbott (Austin, TX)
- …oversight on product, process, and equipment related changes and implementations ( validation & change control). Specifically, + Provide quality support and oversight ... (approval) of process and equipment validation and change control records and activities, + Ensure...demonstrated use of Quality tools/methodologies. + Detailed knowledge of FDA , GMP, ISO 13485, and ISO 14971. + Solid… more
- Contract Pharmacal Corp (Hauppauge, NY)
- Junior Engineer; Validation Hauppauge, NY (http://maps.google.com/maps?q=145+Oser+Avenue+Hauppauge+NY+USA+11788) Apply Description Position Summary: The Junior ... Validation Engineer (Technical Services) is responsible for performing process validation , cleaning validation and equipment validation activities for… more
- United Therapeutics (Silver Spring, MD)
- …and other life-threatening diseases. Toward this goal we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials, ... diseases, and other orphan diseases. **How you'll contribute** The Senior Validation Specialist or Engineer, Equipment will perform activities independently in… more
- Danaher Corporation (Muskegon, MI)
- …of solutions that safeguard and improve human health. We are looking for a Validation Engineer to work with our expert engineering teams to support the multiyear ... travel both within the United States and to Europe. What you'll do As validation engineer you are responsible for coordination and execution of validation … more
- PACIV (Indianapolis, IN)
- …of all system lifecycle deliverables from Commissioning & Qualification (C&Q) and Computer System Validation (CSV) documents through System Retirement. This ... Utilities industries is looking for a full-time employed Senior Validation Engineer based at our USA office (Indianapolis) Job...of industry CSV and C&Q expectations and requirements (eg FDA guidelines, USP, GAMP 5, ISO, etc.) + Actively… more
- ThermoFisher Scientific (Rockville, MD)
- …to play a role in advancing cell therapy and high-value biologics. Join the Validation team and help deliver the services in Cold Chain management **Location** : ... in decision-making. Develop and modify SOPs and WIs related to the validation process. Write reports, procedures, and protocols for cold chain engineering studies… more
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